Bruno Sangro, MD, PhD
Data from the CheckMate-040 trial presented at the 2017 International Liver Congress showed promise for nivolumab (Opdivo) as a second-line therapy for patients with hepatocellular carcinoma (HCC).
, Sangro, head of Hepatology Unit, Internal Medicine Department, Clinica Universidad de Navarra, discussed the CheckMate-040 data and the future of immuno-oncology agents in HCC.
OncLive: What are the significant findings from CheckMate-040?
The trial we presented was a single-arm phase Ib/II open-label trial in which nivolumab was used for patients with advanced HCC for the first time. The population was mostly patients who had been exposed to sorafenib—the only agent approved for use in this patient population—and had either progressed on or were intolerant of sorafenib.
Just to have an idea, the other randomized clinical trials running in the second-line setting of this tumor [have] placebo arms [or] best supportive care arms consistently showing a median OS ranging from 7.5 to 8.5 months. So, observing 16 months is really quite reassuring in terms of antitumor efficacy of the drug.
What is the next step with nivolumab in this disease?
The next step that we have to take is to see if this antitumor effect that we have seen in the second-line can be transferred to the first line as a systemic therapy in advanced cases. This is an objective that is already being pursued, and in fact, a phase III large clinical trial comparing sorafenib versus nivolumab in the first-line setting is ongoing and has already finished recruitment. So, we will learn in the next few months or year if, indeed, nivolumab is also active as a first-line treatment.
In light of these results, how do you predict immuno-oncology agents will progress in this field?
For checkpoint inhibitors, the wide spectrum of activity across many tumor types, including some of the most dreadful tumor types, indicate that as a class, these agents have a strong potential to transform patient care.
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